Department of Rheumatology and Immunology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China.
Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.
J Clin Lab Anal. 2021 Dec;35(12):e24045. doi: 10.1002/jcla.24045. Epub 2021 Oct 21.
Previous studies have demonstrated that Ro60 and Ro52 have different clinical implications, and anti-Ro52 antibodies are an independent serum marker of systemic autoimmune diseases, including Sjögren's syndrome. Many different assays have been adopted to detect anti-Sjögren's syndrome antigen A (SSA)/Ro antibodies, while to date no specific approach has been recommended as optimal for anti-SSA/Ro antibody testing. Herein, we performed a multi-center study to explore the current clinical utility of different strategies for anti-SSA/Ro antibody testing in China.
Twenty-one tertiary care centers were included in this questionnaire-based study. The self-administered questionnaire mainly includes testing methods for anti-SSA/Ro antibodies, reporting system of results, and interpretation of results by clinicians.
Six different methods were applied to detect anti-SSA/Ro antibodies in the 21 centers. Line immunoassay (eight different commercial kits) was the most frequently adopted method (21/21, 100%), with different cutoff values and strategies for intensity stratification. There were two reporting systems: One was reported as "anti-SSA antibodies" and "anti-Ro52 antibodies" (12/21, 57%), while the other was "anti-SSA/Ro60 antibodies" and "anti-SSA/Ro52 antibodies" (9/21, 43%). Notably, six centers (29%) considered either positive anti-Ro60 or anti-Ro52 antibodies as positive anti-SSA antibodies, all of which adopted the latter reporting system.
Significant variabilities existed among anti-SSA/Ro assays. Nearly 30% of centers misinterpreted the definition of positive anti-SSA antibodies, which may be attributed to the confusing reporting systems of line immunoassay. Therefore, we advocate standardization of the nomenclature of anti-SSA/Ro antibodies, changing the "anti-SSA/Ro52" label in favor of the "anti-Ro52" antibodies for a clear designation.
先前的研究表明,Ro60 和 Ro52 具有不同的临床意义,抗 Ro52 抗体是包括干燥综合征在内的系统性自身免疫性疾病的独立血清标志物。已经采用了许多不同的检测方法来检测抗干燥综合征抗原 A(SSA)/Ro 抗体,然而迄今为止,尚未推荐任何特定的方法作为抗 SSA/Ro 抗体检测的最佳方法。在此,我们进行了一项多中心研究,以探索目前在中国用于抗 SSA/Ro 抗体检测的不同策略的临床实用性。
本基于问卷的研究纳入了 21 家三级保健中心。该自我管理问卷主要包括抗 SSA/Ro 抗体的检测方法、结果报告系统以及临床医生对结果的解释。
21 家中心应用了六种不同的方法来检测抗 SSA/Ro 抗体。线免疫分析(八种不同的商业试剂盒)是最常采用的方法(21/21,100%),具有不同的临界值和强度分层策略。有两种报告系统:一种报告为“抗 SSA 抗体”和“抗 Ro52 抗体”(12/21,57%),另一种报告为“抗 SSA/Ro60 抗体”和“抗 SSA/Ro52 抗体”(9/21,43%)。值得注意的是,有 6 家中心(29%)将阳性抗 Ro60 或抗 Ro52 抗体视为阳性抗 SSA 抗体,它们都采用了后者的报告系统。
抗 SSA/Ro 检测方法之间存在显著差异。近 30%的中心错误地解释了阳性抗 SSA 抗体的定义,这可能归因于线免疫分析报告系统的混乱。因此,我们主张标准化抗 SSA/Ro 抗体的命名,将“抗 SSA/Ro52”标签改为“抗 Ro52 抗体”,以明确区分。